{"protocolSection":{"identificationModule":{"nctId":"NCT00887224","orgStudyIdInfo":{"id":"3151A1-3360"},"secondaryIdInfos":[{"id":"B2061004"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Relapse Prevention Study Of Desvenlafaxine Succinate Sustained Release In Outpatients With Major Depressive Disorder","officialTitle":"A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2012-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-06"},"primaryCompletionDateStruct":{"date":"2011-03","type":"ACTUAL"},"completionDateStruct":{"date":"2011-03","type":"ACTUAL"},"studyFirstSubmitDate":"2009-04-22","studyFirstSubmitQcDate":"2009-04-22","studyFirstPostDateStruct":{"date":"2009-04-23","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-03-06","resultsFirstSubmitQcDate":"2012-05-22","resultsFirstPostDateStruct":{"date":"2012-06-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-11-06","lastUpdatePostDateStruct":{"date":"2014-11-21","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.\n\nThe study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety."},"conditionsModule":{"conditions":["Major Depressive Disorder"],"keywords":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":874,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Desvenlafaxine succinate sustained release 50 mg","type":"EXPERIMENTAL","interventionNames":["Drug: Desvenlafaxine succinate sustained release 50 mg","Drug: Desvenlafaxine succinate sustained release 25 mg"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Desvenlafaxine succinate sustained release 50 mg","description":"50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm.","armGroupLabels":["Desvenlafaxine succinate sustained release 50 mg"],"otherNames":["Pristiq"]},{"type":"DRUG","name":"Desvenlafaxine succinate sustained release 25 mg","description":"25 mg tablet for taper, once daily for 1 week","armGroupLabels":["Desvenlafaxine succinate sustained release 50 mg"],"otherNames":["Pristiq"]},{"type":"DRUG","name":"Placebo","description":"Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185","description":"Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).","timeFrame":"Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)"}],"secondaryOutcomes":[{"measure":"Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale","description":"CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.","timeFrame":"Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)"},{"measure":"Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase","description":"CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range of 1 (normal - not ill at all) to 7 (among the most extremely ill). Higher score = more affected. Change from baseline mean=adjusted mean change calculated using mixed-effects model for repeated measures (MMRM).","timeFrame":"Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)"},{"measure":"Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.","timeFrame":"Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)"},{"measure":"Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase","description":"HAM-D6 is a standardized, clinician-administered rating scale is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 (0=none/absent to 2=most severe) and all others are scored 0 to 4 (0=none/absent to 4=most severe). Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline mean=adjusted mean change calculated using MMRM.","timeFrame":"Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322)"},{"measure":"Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26","description":"HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.","timeFrame":"Double-blind phase Week 26 (Study Day 322)"},{"measure":"Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index","description":"WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.","timeFrame":"Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)"},{"measure":"Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase","description":"WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.","timeFrame":"Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)\n* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \\>= 20\n* Clinical Global Impressions Scale-Severity (CGI-S) score of \\>= 4.\n\nExclusion Criteria:\n\n* Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores.\n* Past treatment with desvenlafaxine succinate sustained release.\n* Other eligibility criteria also apply.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call 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Efficacy of Desvenlafaxine 50 mg/d Versus Placebo in the Long-Term Treatment of Major Depressive Disorder: A Randomized, Double-Blind Trial. Prim Care Companion CNS Disord. 2015 Aug 27;17(4):10.4088/PCC.14m01711. doi: 10.4088/PCC.14m01711. eCollection 2015."},{"pmid":"26644956","type":"DERIVED","citation":"McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3):10.4088/PCC.14m01741. doi: 10.4088/PCC.14m01741. eCollection 2015."},{"pmid":"26137355","type":"DERIVED","citation":"McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1):10.4088/PCC.14m01681. doi: 10.4088/PCC.14m01681. eCollection 2015."},{"pmid":"25758058","type":"DERIVED","citation":"Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26."},{"pmid":"23473348","type":"DERIVED","citation":"Rosenthal JZ, Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder:a randomized controlled trial. J Clin Psychiatry. 2013 Feb;74(2):158-66. doi: 10.4088/JCP.12m07974."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3151A1-3360&StudyName=Relapse%20Prevention%20Study%20Of%20Desvenlafaxine%20Succinate%20Sustained%20Release%20In%20Outpatients%20With%20Major%20Depressive%20Disorder"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"1072 participants were screened, 874 were enrolled into Desvenlafaxine succinate sustained release (DVS SR) open-label 8-week response phase; 659 entered into 12-week open label stability phase. After 20 weeks of open-label treatment 548 subjects were randomized to the 6-month double-blind phase to receive either placebo or to continue with DVS SR.","groups":[{"id":"FG000","title":"DVS SR 50 mg (Open-label Phase)","description":"Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population)."},{"id":"FG001","title":"Placebo (Double-blind Phase)","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."},{"id":"FG002","title":"DVS SR 50 mg (Double-blind Phase)","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."}],"periods":[{"title":"Open-label Response (OLR) 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Baseline Gender reported for participants entering the Open-label phase at study start.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Female","categories":[{"measurements":[{"groupId":"BG000","value":"608"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"608"}]}]},{"title":"Male","categories":[{"measurements":[{"groupId":"BG000","value":"266"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"266"}]}]}]},{"title":"Number of participants per categorical score on Clinical Global Impression-Improvement (CGI-I) scale","description":"CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. 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Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).","populationDescription":"All Randomized population: all participants randomly assigned to the Double-blind treatment phase of the study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent estimated probability","timeFrame":"Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD."},{"id":"OG001","title":"DVS SR 50 mg","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"276"},{"groupId":"OG001","value":"272"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30.2"},{"groupId":"OG001","value":"14.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"Significance declared if p-value ≤0.05. 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measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"0.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.15","ciUpperLimit":"0.91"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 3","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0023","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.21","ciUpperLimit":"0.95"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 4","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"0.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.49","ciUpperLimit":"1.28"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 6","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.43","ciUpperLimit":"1.32"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 10","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"1.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.58","ciUpperLimit":"1.58"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.66","ciUpperLimit":"1.58"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 18","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"1.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.76","ciUpperLimit":"1.83"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 22","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"1.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"1.76"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 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Nine items are scored on a 3 point scale (0=none/absent to 2=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe) for a maximum total score of 50; higher score indicates more depression. Remission defined as HAM-D17 total score ≤7.","populationDescription":"All Randomized population. N=number of participants with analyzable data at observation based on Last Observation Carried Forward (LOCF).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Double-blind phase Week 26 (Study Day 322)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD."},{"id":"OG001","title":"DVS SR 50 mg","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"273"},{"groupId":"OG001","value":"270"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"201"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Wald 95% CI for adjusted odds ratio.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.","statisticalMethod":"Regression, Logistic","paramType":"Adjusted odds ratio","paramValue":"2.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.93","ciUpperLimit":"4.20"}]},{"type":"SECONDARY","title":"Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index","description":"WHO-5 evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions (felt cheerful, in good spirits; felt calm, relaxed; felt active, vigorous; woke up fresh, rested; and daily life filled with things that are interesting) each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score ranged from 0 (worst possible quality of life) to 25 (best possible quality of life). Change from baseline mean=adjusted mean change calculated using MMRM.","populationDescription":"All Randomized population. N=number of participants with analyzable data at observation.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD."},{"id":"OG001","title":"DVS SR 50 mg","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"261"}]}],"classes":[{"title":"Change from baseline at DB Week 14","categories":[{"measurements":[{"groupId":"OG000","value":"-2.51","spread":"0.35"},{"groupId":"OG001","value":"-0.38","spread":"2.36"}]}]},{"title":"Change from baseline at DB Week 26","categories":[{"measurements":[{"groupId":"OG000","value":"-2.36","spread":"0.38"},{"groupId":"OG001","value":"-0.04","spread":"0.37"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"-2.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.03","ciUpperLimit":"-1.24"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 26","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"-2.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.29","ciUpperLimit":"-1.34"}]},{"type":"SECONDARY","title":"Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase","description":"WPAI is a 6 question participant rated questionnaire to determine the degree to which depression affected work productivity while at work and affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combined absenteeism and presenteeism and percentage of impairment in activities performed outside of work. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher score indicated greater impairment and less productivity.","populationDescription":"All Randomized population. Change from baseline (Bsl) mean=adjusted mean change calculated using MMRM.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"scores on a scale","timeFrame":"Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD."},{"id":"OG001","title":"DVS SR 50 mg","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"265"},{"groupId":"OG001","value":"261"}]}],"classes":[{"title":"Change from Bsl at DB Week 14: Absenteeism","categories":[{"measurements":[{"groupId":"OG000","value":"1.64","spread":"1.72"},{"groupId":"OG001","value":"0.62","spread":"1.87"}]}]},{"title":"Change from Bsl at DB Week 14: Presenteeism","categories":[{"measurements":[{"groupId":"OG000","value":"9.35","spread":"2.30"},{"groupId":"OG001","value":"2.44","spread":"2.55"}]}]},{"title":"Change from Bsl DB Week 14: Work productivity loss","categories":[{"measurements":[{"groupId":"OG000","value":"9.66","spread":"2.48"},{"groupId":"OG001","value":"2.19","spread":"2.75"}]}]},{"title":"Change from Bsl at DB Week 14: Activity impairment","categories":[{"measurements":[{"groupId":"OG000","value":"11.02","spread":"1.62"},{"groupId":"OG001","value":"3.45","spread":"1.66"}]}]},{"title":"Change from Bsl at DB Week 26: Absenteeism","categories":[{"measurements":[{"groupId":"OG000","value":"0.43","spread":"2.05"},{"groupId":"OG001","value":"0.77","spread":"2.08"}]}]},{"title":"Change from Bsl at DB Week 26: Presenteeism","categories":[{"measurements":[{"groupId":"OG000","value":"7.75","spread":"2.35"},{"groupId":"OG001","value":"-0.49","spread":"2.41"}]}]},{"title":"Change from Bsl DB Week 26: Work productivity loss","categories":[{"measurements":[{"groupId":"OG000","value":"8.47","spread":"2.56"},{"groupId":"OG001","value":"-0.00","spread":"2.63"}]}]},{"title":"Change from Bsl at DB Week 26: Activity impairment","categories":[{"measurements":[{"groupId":"OG000","value":"9.67","spread":"1.75"},{"groupId":"OG001","value":"2.05","spread":"1.69"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14 Absenteeism","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6772","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"1.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.82","ciUpperLimit":"5.87"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 26 Absenteeism","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9059","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-5.91","ciUpperLimit":"5.24"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14 Presenteeism","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0414","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"6.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.27","ciUpperLimit":"13.55"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 26 Presenteeism","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0129","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"8.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.77","ciUpperLimit":"14.71"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14 Work Productivity Loss","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0402","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"7.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.34","ciUpperLimit":"14.61"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 26 Work Productivity Loss","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0187","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"8.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.43","ciUpperLimit":"15.53"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 14 Activity Impairment","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"7.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.33","ciUpperLimit":"11.80"},{"groupIds":["OG000","OG001"],"groupDescription":"Adjusted difference from placebo: Week 26 Activity Impairment","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment\\*visit with \"Unstructured\" covariance structure.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed-effects model for repeated measures (MMRM).","paramType":"Mean Difference (Final Values)","paramValue":"7.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.14","ciUpperLimit":"12.10"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Events collected from the time informed consent in Open-Label phase (OL) through 15 days after last dose or up to study day 336.","description":"Same event may appear as both an AE and SAE, however, are presented as distinct events; may be categorized as SAE in 1 subject and as non-SAE in another, or 1 subject may have experienced both an SAE and non-SAE during study. Participants are counted multiple times: transition from OL Response to OL Stability phase; then as randomized to DB phase.","eventGroups":[{"id":"EG000","title":"DVS SR 50 mg (Open-label Response Phase)","description":"DVS SR 50 mg PO QD for 8 weeks.","seriousNumAffected":9,"seriousNumAtRisk":874,"otherNumAffected":609,"otherNumAtRisk":874},{"id":"EG001","title":"DVS SR 50 mg (Open Label Stability Phase)","description":"DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.","seriousNumAffected":6,"seriousNumAtRisk":659,"otherNumAffected":36,"otherNumAtRisk":659},{"id":"EG002","title":"DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)","description":"Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.","seriousNumAffected":4,"seriousNumAtRisk":326,"otherNumAffected":8,"otherNumAtRisk":326},{"id":"EG003","title":"Placebo (Double-blind Phase)","description":"Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.","seriousNumAffected":7,"seriousNumAtRisk":276,"otherNumAffected":81,"otherNumAtRisk":276},{"id":"EG004","title":"DVS SR 50 mg (Double-blind Phase)","description":"DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.","seriousNumAffected":8,"seriousNumAtRisk":272,"otherNumAffected":55,"otherNumAtRisk":272},{"id":"EG005","title":"Placebo (DB Taper / DB Post Study Follow Up)","description":"Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.","seriousNumAffected":1,"seriousNumAtRisk":276,"otherNumAffected":14,"otherNumAtRisk":276},{"id":"EG006","title":"DVS SR 50 mg (DB Taper / DB Post Study Follow Up)","description":"Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.","seriousNumAffected":1,"seriousNumAtRisk":272,"otherNumAffected":23,"otherNumAtRisk":272}],"seriousEvents":[{"term":"Atrioventricular block second degree","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":874},{"groupId":"EG001","numAffected":0,"numAtRisk":659},{"groupId":"EG002","numAffected":0,"numAtRisk":326},{"groupId":"EG003","numAffected":0,"numAtRisk":276},{"groupId":"EG004","numAffected":0,"numAtRisk":272},{"groupId":"EG005","numAffected":0,"numAtRisk":276},{"groupId":"EG006","numAffected":0,"numAtRisk":272}]},{"term":"Subcutaneous abscess","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":874},{"groupId":"EG001","numAffected":0,"numAtRisk":659},{"groupId":"EG002","numAffected":0,"numAtRisk":326},{"groupId":"EG003","numAffected":0,"numAtRisk":276},{"groupId":"EG004","numAffected":0,"numAtRisk":272},{"groupId":"EG005","numAffected":0,"numAtRisk":276},{"groupId":"EG006","numAffected":0,"numAtRisk":272}]},{"term":"Intentional overdose","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":874},{"groupId":"EG001","numAffected":0,"numAtRisk":659},{"groupId":"EG002","numAffected":0,"numAtRisk":326},{"groupId":"EG003","numAffected":0,"numAtRisk":276},{"groupId":"EG004","numAffected":0,"numAtRisk":272},{"groupId":"EG005","numAffected":0,"numAtRisk":276},{"groupId":"EG006","numAffected":0,"numAtRisk":272}]},{"term":"Abnormal behaviour","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 14.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":874},{"groupId":"EG001","numAffected":0,"numAtRisk":659},{"groupId":"EG002","numAffected":0,"numAtRisk":326},{"groupId":"EG003","numAffected":0,"numAtRisk":276},{"groupId":"EG004","numAffected":0,"numAtRisk":272},{"groupId":"EG005","numAffected":0,"numAtRisk":276},{"groupId":"EG006","numAffected":0,"numAtRisk":272}]},{"term":"Aggression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 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